Effects of Victoza® Versus Lyxumia® on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion
- Registration Number
- NCT02231658
- Lead Sponsor
- Profil Institut für Stoffwechselforschung GmbH
- Brief Summary
The present study will compare lixisenatide and liraglutide in a population of subjects with T2DM not optimally controlled on OADs and / or insulin, which is the target population for these medications.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 109
Inclusion Criteria
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- Male or female aged 18-65 years (both inclusive)
- T2DM diagnosis
Exclusion Criteria
- Contraindications (including known or suspected hypersensitivity) to GLP-1 mimetics
- Use of GLP-1 mimetics or DPP-IV inhibitors
- Clinically relevant dysglycaemia as indicated by HbA1C ≥ 10%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Liraglutide Liraglutide The highest injected once daily dose will be 1.8 mg s.c. for liraglutide. Lixisenatide Lixisenatide The highest injected once daily dose will be 20µg s.c. for lixisenatide.
- Primary Outcome Measures
Name Time Method Change from baseline (week -1) in the number of reflux episodes 24 hours after 10 weeks of treatment
- Secondary Outcome Measures
Name Time Method Change from baseline (week -1) in the time of pH < 4.0 in the lower third of the oesophagus After 10 weeks of treatment
Trial Locations
- Locations (2)
St. Josef-Hospital, Universitätsklinik
🇩🇪Bochum, Germany
Profil Institut für Stoffwechselforschung GmbH
🇩🇪Neuss, Germany